RESUMO
BACKGROUND: There are limited efficacy and safety data for buprenorphine/naloxone treatment in adolescents, and little is known about the incidence and prevalence of liver function abnormalities in young patients using buprenorphine/naloxone. OBJECTIVES: To assess the changes in liver enzyme levels associated with buprenorphine/naloxone treatment and co-medication with psychotropic agents among opioid dependent subjects aged 15-18 years. METHODS: Liver enzyme levels (ALT and AST) were evaluated among 59 adolescent subjects before and following eight weeks of buprenorphine/naloxone treatment. RESULTS: The frequency of additional psychotropic use was 60%. The patients' mean liver enzyme levels at weeks 2 and 4 were significantly higher than the baseline (ALT: p < 0.0001 and p = 0.003, and AST: p < 0.0001 and p = 0.016, respectively). However, there was no statistically significant difference in AST and ALT levels between the baseline and week 8. The majority of the abnormalities seen were clinically nonsignificant elevations (less than two times the upper limit of normal). It is plausible that the abnormalities in liver enzymes could have been mediated by the use of psychotropic medications. CONCLUSIONS: Buprenorphine/naloxone was well tolerated in most adolescent patients, besides clinically nonsignificant liver enzyme elevations. Psychotropic medications may have been associated with the liver enzyme changes early in the course of treatment. Nevertheless, given the relatively small number of adolescents studied to date with buprenorphine/naloxone, additional studies evaluating liver enzymes in young patients receiving buprenorphine/naloxone (and no other psychotropics) are needed.
